title: Phase II study of nedaplatin and docetaxel in patients with advanced squamous cell carcinoma of the lung.
abstract: BACKGROUND
  The treatment of squamous cell carcinoma of the lung has not advanced sufficiently. Nedaplatin is a second-generation platinum compound that is active against squamous cell carcinoma of the lung, with a response rate of ~40%.
  
  
  METHODS
  Eligible patients with advanced squamous cell carcinoma of the lung were treated with docetaxel (60 mg/m(2)) and nedaplatin (100 mg/m(2)) administered i.v. on day 1; these doses were determined in an earlier phase I study. The treatment cycles were repeated every 3 weeks. The primary end point was the response rate, and the secondary end points were overall survival, progression-free survival, and toxicity.
  
  
  RESULTS
  Twenty-one patients were enrolled. Eighteen of the patients were male, and the median age was 67 years. The objective response rate was 62%. The median progression-free survival time was 7.4 months. The median survival time was 16.1 months, and the 1-year survival rate was 66.7% (95% confidence interval 46.5% to 86.8%). The most common adverse event was neutropenia (grade 3/4, 86%). Non-hematological toxic effects were relatively mild. One patient died of sepsis.
  
  
  CONCLUSIONS
  Combination chemotherapy with nedaplatin and docetaxel is highly active and has an acceptable toxicity. Further investigation of nedaplatin and docetaxel is warranted.
authors.affiliation: Department of Medical Oncology, Toranomon Hospital, Tokyo; Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Naito
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa; Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: kkubota@ncc.go.jp.
authors.forename: K
authors.initials: K
authors.lastname: Kubota
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: H
authors.initials: H
authors.lastname: Ohmatsu
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: K
authors.initials: K
authors.lastname: Goto
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: S
authors.initials: S
authors.lastname: Niho
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: K
authors.initials: K
authors.lastname: Yoh
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Y
authors.initials: Y
authors.lastname: Ohe
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin